Medline MDSM611503Recalls & reported problems
Medline Industries, Inc. · ELECTRODE, ECG, FOAM, 3PK · Class 2
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 50884389830329), received between Sep 15, 2026 and Sep 30, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Loss of or Failure to Bond2
- Overheating of Device1
- Patient Device Interaction Problem1
- Signal Artifact/Noise1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Blister1
- Skin Inflammation/ Irritation1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Signal Artifact/Noise; Loss of or Failure to Bond
It was reported that updated packaged sku is less durable, button connectors are coming apart from pad and they are not sticking and generating a lot of artifact when used.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950260 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937624 ↗MalfunctionSep 22, 2026Patient Device Interaction Problem
It was reported that the patient had a post op/follow up after a colonoscopy and had irritation on the skin where the ecg was replaced; skin reaction.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50855331 ↗MalfunctionSep 15, 2026Overheating of Device
It was reported that "NON-MRI ELECTRODES NOT REMOVED PRIOR TO MRI. ELECTRODE HEATED UP AND CAUSED BLISTER."
Patient problems: Blister; Skin Inflammation/ Irritation
MAUDE report 50774147 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.